Accurate Data Entry Indispensable in Clinical Trial Management

Clinical trials involve large volume data entry, and outsourced solutions such as data entry services prove helpful. Data can be entered in different ways – it can be done in the form of direct entry into the computer from paper-based case report forms (CRFs); it can be in the form of scanning (optical mark reading) or optical character recognition (OCR) for scannable/faxable forms.

Earlier, clinical trials were conducted at a single study site by a team but now multi-center, multinational clinical trials are common with complex protocols. In this constantly developing technology era, paper-based processes and methods are still used in clinical trials. Researchers collect data using paper case report forms. These reports are then digitally transcribed by administrative staff. The data is checked for accuracy, and all queries will have to be fed back to each research site for correction and clarification. These methods require staff to be present and can be demanding and time consuming. Now, electronic data capture systems are becoming popular in clinical trial data management. However, more efficient use can be made of these systems, as researchers point out.

The latest approach, published in Trials, highlights the use of a web-accessible database incorporating randomization and data collection in a multisite clinical trial of a complex physical activity intervention. This database was developed with the objective of dealing with the multiple challenges typically seen in multicentre coordinated trials, and also to help them monitor fidelity that is vital to the delivery of a complex intervention. The team used iPad tablets to control the interaction with the database and maximize the tools available in a mobile device for use within the trial.

Research workers at sites were provided with an iPad for data collection, which allowed the trial team to observe and judge the reliability of the involvement. Data collection was performed in real time during participant visits using mobile devices and immediate data collection allowed for real time data tracking. This led to timely identification and modification of primary product data. The iPad camera was used to digitally record participant completed forms, screening logs and staff training sessions. After forms processing, these were then uploaded to the central database using a secure file transfer system, allowing centralized access to these records immediately. Any chance of errors was minimized with the help of strict data validations and by employing 100% QA for the data at the central site.

When communication was made easier, there were other benefits as well such as

improving relationships

retaining engagement with the researchers at each site

increased confidence in the technology and skill levels

The time and resources needed for data cleaning and management that is to be done before analysis were considerably reduced. This novel system benefited not only in terms of the efficiency ofclinical trial management, but also helped in the successful collection of all primary outcome data. The researchers believe that the ability of research staff to upload visit data immediately and the added ability to photograph and securely transfer participant completed records contributed to the high rate of return of expected data.

This system provides many benefits, that’s true. However, it may be difficult to implement in regions where there is no/poor Wi-Fi or mobile data service coverage. You need to ensure a reliable connection of your device to ensure secure data upload. There should also be foolproof contingencies for “mission critical” processes.

For paper-based processes in clinical trials, researchers can always count on data entry outsourcing and save resources, time and effort. Not only in clinical trials, in other research projects using paper-based data also, this is a feasible solution when you are not using electronic data collection tools and other data entry software. Reliable providers would minimize any chance of errors with the help of double data entry whereby two data entry professionals would enter the same information. A verification program is used to spot any differences between the two files. Discrepancies if any are identified and the required change are made. This will help preserve the important clinical data in an organized, accurate and complete state.